Duque De Caxias

This research aims to evaluate whether benzathine penicillin can prevent syphilis in pregnant women who are at higher risk of infection during pregnancy. The study focuses on pregnancy-related syphilis and its transmission to infants, particularly in Rio de Janeiro, Brazil, where rates have been rising. Researchers want to understand if adding benzathine penicillin injections to routine counseling and testing can reduce maternal and congenital syphilis cases and assess the safety of this treatment. Participants will be randomly assigned to one of two groups starting at 28 weeks of pregnancy: one group will receive monthly counseling, intensified syphilis testing, and benzathine penicillin injections at 28, 32, and 36 weeks; the other will receive counseling and intensified testing only, which is considered enhanced standard care. Benzathine penicillin is given as an intramuscular injection of 2.4 million units. The study includes monthly clinic visits for testing and injections during the third trimester. Throughout the study, participants will visit the clinic monthly for injections and blood tests to monitor for syphilis infection and any reactions to treatment. The primary outcome is absence of maternal syphilis infection at delivery, confirmed by specific blood tests, and absence of congenital syphilis in newborns. Each participant will be involved for about 4 to 5 months, from 28 weeks of pregnancy until delivery, with infants followed during their first month of life. The total study duration is about 3.5 years for enrollment plus additional follow-up and analysis time.